he study to confirm the safety of excessive intake of a food containing lactic acid bacteria for improvement of oral health: An open trial
- Conditions
- one (Healthy adults)
- Registration Number
- JPRN-UMIN000029105
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Subject who are diagnosed with caries (C3 or more) or severe periodontal disease. (2) Subject who have illness such as diabetes, chronic kidney disease, gastrointestinal disease, lung disease, malignant tumor and so on, and are taking medicine. (3) Subjects who are using products that have halitosis preventing effect such as mouse washes daily. (4) Subjects who have gastrointestinal disease or history of gastrointestinal surgery that may affect digestion and absorption. (5) Subject whose saliva secretion by stimulation during 5 minute is less than 3.0 mL. (6) Subjects whose pH of saliva is 6.2 or less. (7) Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test. (8) Subjects who have food allergy, lactose intolerance, and/or feeling of unwellness by the dairy products. (9) Subjects who are wearing removal dentures. (10) Subjects who are pregnant, or who are planning to become pregnant or breast-feeding during the test. (11) Persons who are participating or intend to participate in other tests for taking foods, drugs, and/or cosmetics. (12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interview (subjective symptom) Gingival index Plaque index Periodontal index Oral mucosa Staining of tooth Saliva secretion Saliva pH General clinical examination Hematologic test: White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, MCV, MCH, MCHC Biochemical analysis: Total protein, Albumin, A/G, AST (GOT), ALT (GPT), LD (LDH), Total bilirubin, ALP, gamma-GTP, Urea nitrogen (UN), Creatinine, Uric acid (UA), Sodium, Potassium, Chlorine, Calcium, Magnesium, Total cholesterol, LDL-cholesterol, TG (triglyceride), fasting glucose Urine test: Protein, Glucose, Urobilinogen, Bilirubin, pH, Specific gravity, Ketone, and Blood Blood pressure/pulse
- Secondary Outcome Measures
Name Time Method